| CTRI Number |
CTRI/2024/03/064619 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
04/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Dummy Patient Based Crisis Management Training for Post-graduate Students in Anaesthesiology |
|
Scientific Title of Study
|
Effectiveness of Simulation Based Training in Improving the Performance of Non-Technical Skills Among Post graduate Students During Anaesthesia Crisis Resource Management |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karuna Taksande |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of medical science and research |
| Address |
Department of Anaesthesiology
3rd Floor, Shalinitai Superspecialty Building, Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
7722037738 |
| Fax |
|
| Email |
karunahp1878@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amol Singam |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of medical science and research |
| Address |
Department of Anaesthesiology
3rd Floor, Shalinitai Superspecialty building, Sawangi
Wardha
MAHARASHTRA
44001
India |
| Phone |
9422538005 |
| Fax |
|
| Email |
amolsingam@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Karuna Taksande |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of medical science and research |
| Address |
Department of Anaesthesiology, 3rd floor,
Shalinitai Superspecialty Hospital Building, Sawangi
Wardha
MAHARASHTRA
44001
India |
| Phone |
9422538005 |
| Fax |
|
| Email |
karunahp1878@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College Sawangi Wardha |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Datta Meghe Institute of Medical Science and Research
Wardha |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Karuna Taksande |
Jawaharlal Nehru medical college |
Department of Anaesthesiology, Shalinitai Superspecialty Hospital Building,
Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA |
7722037738
karunahp1878@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Training on Dummies For Post graduation Students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1st year anaesthesiology residents will be taught simulation based anesthsia crisis resource management |
The intervention will be given as planned sessions over a period of 2 years and their performance will be assessed at the end of 2 years. |
| Comparator Agent |
2nd year anaesthesiology residents will be taught simulation based anesthsia crisis resource management |
The intervention will be given as planned sessions over a period of 2 years and their performance will be assessed at the end of 2 years. |
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
34.00 Year(s) |
| Gender |
Both |
| Details |
Anaesthesia Post Graduation Students of 1st year and 2nd Year |
|
| ExclusionCriteria |
| Details |
Anaesthesia Post Graduation Students Not Willing to Participate From 1st year and 2nd Year |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To learn generic principle of complex problem solving, decision making, resource management
and team behaviour. |
3 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve residents medical/technical Cognitive and Social skills in the Recognition and Treatment of Realisatic , Complex medical Situation |
3 years |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This research focuses on training postgraduate students in simulation-based methods to enhance their non-technical skills in managing resources during the anesthesia crisis |